BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 GAS BLENDER

    MDR report key: 3592679 · Received January 6, 2014

    Report

    Report Number
    1718850-2013-00316
    Event Type
    Other
    Date Received
    January 6, 2014
    Date of Event
    August 22, 2013
    Report Date
    December 10, 2013
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTX
    PMA / PMN Number
    K101046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP SERVICE REP, THE PERFUSIONIST REPORTED THAT THE S5 GAS BLENDER HAD NOT MAINTAINED THE SET FLOW RATE DURING RECENT SET-UPS AND PROCEDURES. THE CLINICIAN WOULD RESET THE FLOW RATE TO CORRECT THE PROBLEM AND THERE HAD BEEN NO PT CONSEQUENCES. THE BLENDER HAS BEEN REPLACED. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE VISIT AT A CUSTOMER FACILITY BY A SORIN GROUP SERVICE REP, THE PERFUSIONIST REPORTED THAT THE S5 GAS BLENDER HAD NOT MAINTAINED THE SET FLOW RATE DURING RECENT SET-UPS AND PROCEDURES. THE CLINICIAN WOULD RESET THE FLOW RATE TO CORRECT THE PROBLEM AND THERE HAD BEEN NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8583 S5 GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SORIN GROUP DEUTSCHLAND 25-40-45 NA

    Patients

    Seq Age Sex Outcome Treatment
    1